Senseonics(US:SENS)2024-02-29 23:24PART I This part details the company's business operations, significant risks, regulatory compliance, and corporate information Item 1. Business Senseonics Holdings, Inc. is a medical technology company specializing in long-term implantable continuous glucose monitoring (CGM) systems, primarily Eversense. The company focuses on product development and manufacturing, while its partner, Ascensia Diabetes Care Holdings AG, handles global commercialization, sales, marketing, and customer support. Recent developments include FDA approval and CE mark for the 180-day Eversense E3 system, expanded Medicare coverage, and ongoing pivotal studies for a 365-day sensor. The company's strategy emphasizes increasing market awareness, expanding the inserter network, and securing favorable reimbursement - Senseonics is a medical technology company focused on developing and manufacturing long-term implantable glucose monitoring products, with Eversense E3 CGM system designed for up to six months of continuous glucose measurement19 - The company's commercialization strategy relies on an exclusive agreement with Ascensia Diabetes Care Holdings AG for worldwide distribution, with Senseonics responsible for product development and manufacturing, and Ascensia for sales, marketing, and customer support2241 - Key recent developments include FDA approval of the 180-day Eversense E3 CGM system in February 2022 and its subsequent commercialization in the U.S. and EEA, as well as expanded Medicare coverage for Eversense E3 to include all insulin users and non-insulin users with problematic hypoglycemia, effective February 25, 20242326 - The ENHANCE pivotal study for a 365-day Eversense system has completed adult enrollment and data analysis, with an FDA submission expected soon for a new product targeting 365-day duration and once-per-week calibration2054 Overview This section provides a general introduction to the company's business and products Significant Recent Developments This section highlights key recent achievements and milestones for the company Background This section provides historical context and foundational information about the company Commercial Strategy This section outlines the company's approach to market its products and achieve sales growth Collaboration and Commercialization Agreement with Ascensia Diabetes Care Holdings AG This section details the strategic partnership for global product commercialization Clinical Development and Regulatory Pathway This section describes the clinical trials and regulatory processes for product approvals Overview This section provides a general summary of the clinical development and regulatory process United States Pivotal Trials This section details the key clinical trials conducted in the United States for product approval PRECISE II Trial This section describes the PRECISE II clinical trial PROMISE Trial This section describes the PROMISE clinical trial ENHANCE Trial This section describes the ENHANCE clinical trial Our Technology This section describes the core technological components of the company's products Sensor This section details the design and function of the glucose sensor Smart Transmitter This section describes the features and capabilities of the smart transmitter Mobile App This section outlines the functionality of the accompanying mobile application Future Product Development This section discusses ongoing and planned initiatives for new product innovation and enhancements Sales and Marketing This section describes the strategies and activities for promoting and selling products Reimbursement This section addresses the coverage and payment policies for the company's products Coverage in the United States This section details product reimbursement policies within the United States Coverage Outside the United States This section details product reimbursement policies in international markets Manufacturing and Quality Assurance This section describes the production processes and quality control measures for products Competition This section analyzes the competitive landscape and key rivals in the market Intellectual Property This section outlines the company's strategies for protecting its proprietary technologies and innovations Patents This section details the company's patent portfolio Trademarks This section details the company's registered trademarks Trade Secrets This section describes the company's protection of confidential business information Government Regulation This section describes the extensive regulatory framework governing the company's operations and products Regulation by the FDA This section details the regulatory oversight by the U.S. Food and Drug Administration International Regulation This section describes regulatory requirements in markets outside the United States Other Regulatory Requirements This section covers additional regulatory obligations beyond core product approvals Health Insurance Portability and Accountability Act of 1996 and Other Foreign and State Laws and Regulations Affecting the Transmission, Security and Privacy of Personal Information This section addresses laws governing the privacy and security of health and personal information Fraud and Abuse Laws This section discusses regulations designed to prevent healthcare fraud and abuse Federal Anti-Kickback and Self-Referral Laws This section details federal laws prohibiting kickbacks and self-referrals in healthcare Federal False Claims Act & HIPAA This section covers federal laws related to false claims and health information privacy Civil Monetary Penalties Law This section describes laws imposing civil monetary penalties for certain healthcare offenses State Fraud and Abuse Provisions This section outlines state-level regulations addressing fraud and abuse Physician Payments Sunshine Act This section details the law requiring disclosure of payments to physicians and teaching hospitals Healthcare and Regulatory Reform This section discusses the impact of broader healthcare and regulatory changes Brexit and the Regulatory Framework in the United Kingdom This section addresses the implications of Brexit on the UK regulatory environment U.S. Foreign Corrupt Practices Act This section covers the U.S. law prohibiting bribery of foreign officials UK Bribery Act and other anti-corruption laws This section discusses anti-corruption legislation, including the UK Bribery Act Environmental Health and Safety Regulations This section outlines compliance with environmental, health, and safety standards Employees and Human Capital Resources This section describes the company's workforce, culture, and human resource management Culture This section describes the company's organizational culture and values Employee Health & Wellbeing This section details initiatives supporting employee health and wellness Organizational Development This section discusses strategies for enhancing organizational effectiveness and growth Diversity, Equity, and Inclusion This section outlines the company's commitment to diversity, equity, and inclusion initiatives Total Rewards This section describes the comprehensive compensation and benefits programs for employees Corporate Information This section provides general information about the company's corporate structure and details Available Information This section specifies where public information about the company can be accessed Item 1A. Risk Factors The company faces numerous risks, including significant operating losses since inception and uncertainty about future profitability. Its success heavily relies on the commercialization agreement with Ascensia, which carries risks if performance is unsatisfactory. The highly competitive CGM market, lengthy and expensive product development, and extensive governmental regulations (FDA, international) pose substantial challenges. Financial risks include the need for significant sales to achieve profitability, potential fluctuations in operating results, and substantial debt obligations. Operational risks encompass reliance on third-party manufacturers and suppliers, potential product defects, and the need to continuously innovate. Data privacy and security, including the use of AI, are also growing concerns, alongside the volatility of the company's common stock and potential dilution from convertible securities - The company has incurred significant net losses since inception, with a net loss of $60.4 million in 2023 and an accumulated deficit of $869.3 million as of December 31, 2023, and does not expect to be profitable for at least the next several years167168 - Future revenue is substantially dependent on the success of the Commercialization Agreement with Ascensia; unsatisfactory performance by Ascensia could adversely affect commercialization efforts and financial results169171 - The CGM market is highly competitive, with major players like Dexcom, Medtronic, and Abbott, who possess greater financial resources, established market presence, and advanced technologies (e.g., factory calibration, iCGM indications)179213216 - The company faces risks related to its reliance on third-party manufacturers and suppliers, including potential quality defects, inability to secure components, production capacity issues, and disruptions to facilities191196198 - Extensive governmental regulations (FDA, international) govern product development, manufacturing, marketing, and sales, with non-compliance potentially leading to fines, recalls, and suspension of marketing authorizations199297101115 - The company's stock price has been highly volatile, influenced by factors such as analyst coverage, clinical trial results, financing activities, regulatory approvals, and broader market conditions170354356 Summary of Risks Affecting Our Business This section provides a high-level overview of the principal risks impacting the company's operations Risks Relating to our Business and our Industry This section details specific risks inherent to the company's business model and the broader industry Risks Related to our Financial Results and Need for Financing This section outlines financial risks, including profitability, liquidity, and capital requirements Risks Related to Development of our Products This section addresses challenges and uncertainties associated with product research and development Risks Related to Employee Matters and Managing our Growth This section covers risks associated with human capital, organizational growth, and management Risks Related to our Intellectual Property This section discusses potential threats to the company's patents, trademarks, and trade secrets Risks Related to our Legal and Regulatory Environment This section addresses compliance risks, potential litigation, and the impact of evolving regulations Risks Related to our Common Stock This section outlines factors that could affect the trading price and liquidity of the company's stock Item 1B. Unresolved Staff Comments The company reported no unresolved staff comments from the SEC - No unresolved staff comments were reported386 Item 1C. Cybersecurity The company has implemented various information security processes to identify, assess, and manage cybersecurity risks to its critical systems and data. This includes monitoring threats, conducting vulnerability assessments, and maintaining technical, physical, and organizational security measures. Cybersecurity risk management is integrated into the company's overall risk management, with oversight from the board's audit committee and active involvement from the executive team and head of IT - The company maintains information security processes to identify, assess, and manage cybersecurity threats to its Information Systems and Data, utilizing methods like manual/automated tools, threat environment scans, external audits, and vulnerability assessments387388 - Implemented security measures include incident detection and response, disaster recovery, data encryption, network security controls, access controls, vendor risk management, employee training, penetration testing, and cybersecurity insurance389 - Cybersecurity risk management is integrated into the company's overall risk management, with the board of directors' audit committee overseeing the processes and the executive team, along with the head of IT, responsible for implementation and incident response390394395396397398 Risk management and strategy This section outlines the company's approach to identifying, assessing, and mitigating cybersecurity risks Governance This section describes the oversight structure for cybersecurity risk management within the company Item 2. Properties The company's principal offices are located in Germantown, Maryland, occupying approximately 33,000 square feet under a lease expiring in 2033. An additional 30,500 square feet of office space, decommissioned in 2021, had its lease expire in 2023. The company believes its current facilities are adequate and plans to expand as needed - The company's principal offices are in Germantown, Maryland, with approximately 33,000 square feet of research and office space under a lease expiring in 2033399 - An additional 30,500 square feet of office space, decommissioned in 2021, had its non-cancellable operating sub-lease agreement expire in 2023399 Item 3. Legal Proceedings The company was subject to a civil complaint alleging False Claims Act violations related to marketing practices for its Eversense CGM system. The District Court dismissed the complaint, and this decision was affirmed by the Fifth Circuit on February 28, 2024. Currently, the company is not a party to any other material legal proceedings - A civil complaint alleging False Claims Act violations regarding Eversense CGM system marketing practices was dismissed by the District Court on March 30, 2023, and this dismissal was affirmed by the Fifth Circuit on February 28, 2024401 - The company is not currently involved in any other material legal proceedings, nor is it aware of any pending or threatened legal actions that could significantly impact its business, operating results, or financial condition402 Item 4. Mine Safety Disclosures This item is not applicable to the company - The company is not subject to mine safety disclosures403 PART II This part provides financial market information, management's discussion and analysis, audited financial statements, and disclosures on internal controls Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock is listed on the NYSE American under the symbol "SENS." As of February 23, 2024, there were 530,668,435 shares of common stock outstanding held by 168 record holders. The company has never declared or paid cash dividends and intends to retain future earnings for business operations and expansion, with current debt agreements further restricting dividend payments - The company's common stock is traded on the NYSE American under the symbol "SENS"405 - As of February 23, 2024, there were 530,668,435 shares of common stock outstanding, held by 168 record holders5406 - The company has never paid cash dividends and plans to retain all future earnings for business operations and expansion; current debt agreements also restrict dividend payments367405 Market Information for Common Stock This section provides details on the trading market for the company's common stock Dividend Policy This section outlines the company's approach to dividend payments to shareholders Stockholders This section provides information regarding the company's shareholders Recent Sales of Unregistered Securities This section details any recent issuances of securities not registered under the Securities Act Item 6. [Reserved] This item is reserved and contains no information Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides an overview of Senseonics' financial condition and operational results, highlighting its focus on implantable CGM systems like Eversense E3. The company reported a significant increase in total revenue for 2023, driven by commercial activities and a full year of E3 sales, despite a decrease in gross margin due to sales channel mix and increased manufacturing costs. Research and development expenses rose due to investments in next-generation technologies and clinical studies. The company undertook several financing transactions in 2023 to strengthen its balance sheet, including a new term loan facility and warrant issuances. Cash flow analysis shows increased cash used in operations but a net increase in cash and cash equivalents due to investing and financing activities Consolidated Statements of Operations and Comprehensive (Loss) Income (in thousands) | | 2023 | 2022 | Period Change | | :--- | :--- | :--- | :--- | | Total revenue | $22,390 | $16,389 | $6,001 | | Cost of sales | 19,299 | 13,663 | 5,636 | | Gross profit | $3,091 | $2,726 | $365 | | Research and development expenses | 48,752 | 39,719 | 9,033 | | Selling, general and administrative expenses | 29,942 | 31,634 | (1,692) | | Operating loss | ($75,603) | ($68,627) | ($6,976) | | Total other income, net | 15,211 | 210,746 | (195,535) | | Net (Loss) Income | ($60,392) | $142,119 | ($202,511) | - Total revenue increased by $6.0 million (36.6%) to $22.4 million in 2023 from $16.4 million in 2022, primarily due to increased commercial activities, new patients, and a full year of Eversense E3 revenue, partially offset by lower international sales443 - Gross profit increased by $0.4 million to $3.1 million in 2023, but gross margin decreased from 16.6% in 2022 to 13.8% in 2023, mainly due to sales channel mix and higher raw material prices impacting contract manufacturing costs444 - Research and development expenses increased by $9.1 million to $48.8 million in 2023, driven by investments in next-generation technologies, clinical studies, and an expanded R&D workforce445447 - The company completed several financing transactions in 2023, including a $25.0 million initial term loan (with an additional $10.0 million funded in January 2024), issuance of pre-funded warrants for $15.0 million, and exchanges of 2025 Notes for cash and common stock, to strengthen its balance sheet451452453455 Summary of Cash Flows (in thousands) | | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($70,163) | ($66,312) | | Net cash provided by investing activities | $89,713 | $26,882 | | Net cash provided by financing activities | $20,366 | $41,762 | | Net increase in cash and cash equivalents | $39,916 | $2,332 | Overview This section provides a general introduction to the company's financial performance and outlook Critical Accounting Estimates This section discusses accounting policies that require significant judgment and estimation Revenue This section details the critical accounting estimates related to revenue recognition Derivative Financial Instruments This section discusses critical accounting estimates for derivative financial instruments Results of Operations This section analyzes the company's financial performance over specified periods Comparison of the Years Ended December 31, 2023 and 2022 This section compares the financial results for the fiscal years 2023 and 2022 Components of Results of Operations This section breaks down the individual elements contributing to the company's operating results Total revenue This section analyzes the company's total revenue streams Cost of sales and gross profit This section examines the cost of goods sold and resulting gross profit Research and development expenses This section details expenditures on research and development activities Selling, general and administrative expenses This section analyzes expenses related to sales, marketing, and general corporate administration Total other income, net This section covers non-operating income and expenses Liquidity and Capital Resources This section assesses the company's ability to meet its short-term and long-term financial obligations Warrants This section discusses the company's outstanding warrants Indebtedness This section details the company's debt obligations and financing arrangements Loan and Security Agreement This section describes the terms of the company's loan and security agreement PPP Loan This section provides information on the Paycheck Protection Program loan Convertible Notes This section details the company's convertible debt instruments Funding Requirements and Outlook This section discusses future capital needs and the company's financial projections Cash Flows This section analyzes the sources and uses of cash from operating, investing, and financing activities Net cash used in operating activities This section details cash flows generated or used by the company's core business operations Net cash provided by investing activities This section describes cash flows related to the purchase or sale of assets Net cash provided by financing activities This section outlines cash flows from debt, equity, and dividend transactions Item 7A. Quantitative and Qualitative Disclosures About Market Risk The company's primary market risk exposures are interest rate risk and foreign currency risk. Interest rate risk is minimal due to short-term maturities of cash equivalents and fixed interest rates on notes payable. Foreign currency risk arises from Euro-denominated international sales, but transaction gains and losses have not been material, and the company does not currently use hedging transactions - The company's primary market risk is interest rate sensitivity, but due to short-term maturities of cash equivalents and fixed interest rates on notes payable, an immediate 100 basis point change in interest rates would not materially affect the fair value of cash equivalents487 - Foreign currency risk stems from Euro-denominated international sales, where currency fluctuations can impact U.S. dollar revenue. However, foreign currency transaction gains and losses have not been material, and the company does not currently engage in hedging488 Interest Rate Risk This section assesses the company's exposure to fluctuations in interest rates Foreign Currency Risk This section evaluates the company's exposure to changes in foreign exchange rates Item 8. Financial Statements and Supplementary Data This section presents the audited consolidated financial statements for Senseonics Holdings, Inc. and its subsidiary for the years ended December 31, 2023, and 2022. It includes the Independent Registered Public Accounting Firm's report, consolidated balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' equity, and statements of cash flows. Detailed notes to the financial statements provide critical accounting estimates, revenue recognition policies, information on marketable securities, inventory, debt, equity, stock-based compensation, income taxes, related party transactions, fair value measurements, litigation, and subsequent events - KPMG LLP provided an unqualified opinion on the consolidated financial statements for the years ended December 31, 2023 and 2022, stating they present fairly, in all material respects, the financial position, results of operations, and cash flows in conformity with U.S. GAAP492 Consolidated Balance Sheets (in thousands) | | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Total assets | $138,220 | $177,673 | | Total current liabilities | $17,257 | $31,471 | | Long-term debt and notes payables, net | $41,195 | $56,383 | | Derivative liabilities | $102 | $52,050 | | Other liabilities | $6,214 | $2,689 | | Total liabilities | $64,768 | $142,593 | | Total temporary equity | $37,656 | $37,656 | | Total stockholders' equity (deficit) | $35,796 | ($2,576) | Consolidated Statements of Operations and Comprehensive (Loss) Income (in thousands) | | 2023 | 2022 | | :--- | :--- | :--- | | Total revenue | $22,390 | $16,389 | | Gross profit | $3,091 | $2,726 | | Operating loss | ($75,603) | ($68,627) | | Total other income, net | $15,211 | $210,746 | | Net (Loss) Income | ($60,392) | $142,119 | | Total comprehensive (loss) income | ($59,725) | $141,653 | | Basic net (loss) income per common share | ($0.11) | $0.30 | | Diluted net loss per common share | ($0.11) | ($0.11) | Consolidated Statements of Cash Flows (in thousands) | | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($70,163) | ($66,312) | | Net cash provided by investing activities | $89,713 | $26,882 | | Net cash provided by financing activities | $20,366 | $41,762 | | Net increase in cash and cash equivalents | $39,916 | $2,332 | | Cash and cash equivalents, at ending of period | $75,709 | $35,793 | - The company's accumulated deficit reached $869.3 million as of December 31, 2023, reflecting substantial operating losses since inception, primarily from R&D and commercial launch activities514 - As of December 31, 2023, the company had $109.5 million in cash, cash equivalents, and marketable securities, and management believes existing resources will meet anticipated operating needs for at least the next twelve months450514524 Report of KPMG LLP, Auditor ID:185, Independent Registered Public Accounting Firm This section contains the independent auditor's report on the company's financial statements Consolidated Balance Sheets as of December 31, 2023 and 2022 This section presents the company's financial position at the end of 2023 and 2022 Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2023 and 2022 This section presents the company's financial performance for the fiscal years 2023 and 2022 Consolidated Statements of Changes in Stockholders' Equity for the years ended December 31, 2023 and 2022 This section details changes in the company's equity accounts for 2023 and 2022 Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022 This section presents the company's cash inflows and outflows for the fiscal years 2023 and 2022 Notes to Consolidated Financial Statements This section provides detailed explanations and additional information supporting the financial statements 1. Organization This section describes the company's legal structure and business operations 2. Liquidity and Capital Resources This section details the company's financial liquidity and available capital 3. Summary of Significant Accounting Policies This section outlines the key accounting principles and methods used in preparing financial statements Basis of Presentation This section describes the foundational principles for presenting the financial statements Use of Estimates This section explains the role of management's estimates in financial reporting Cash and Cash Equivalents and Concentration of Credit Risk This section details cash, cash equivalents, and credit risk concentrations Marketable Securities This section describes the accounting for marketable securities Inventory and Obsolescence This section details the accounting policies for inventory and obsolescence Accounts Receivable This section describes the accounting for accounts receivable Property and Equipment, net This section details the accounting for property and equipment Leases This section describes the accounting for lease arrangements Impairment of Long-lived Assets This section details the accounting policy for impairment of long-lived assets Derivative Financial Instruments This section describes the accounting for derivative financial instruments Product Warranty Obligations This section details the accounting for product warranty liabilities Revenue Recognition This section outlines the company's policies for recognizing revenue Cost of Sales This section describes the accounting for the cost of goods sold Research and Development Expenses This section details the accounting for research and development expenditures Selling, General and Administrative Expenses This section describes the accounting for selling, general, and administrative costs Stock-Based Compensation This section details the accounting for stock-based compensation plans Income Taxes This section describes the accounting for income taxes Fair Value of Financial Instruments This section details the fair value measurement of financial instruments Recent Accounting Pronouncements This section discusses the impact of newly issued accounting standards 4. Revenue Recognition This section provides detailed information on the company's revenue recognition policies Revenues by geographic region This section breaks down revenue generated from different geographical areas Contract Assets This section describes the company's contract assets Concentration of Revenues and Customers This section identifies significant concentrations in revenue and customer base 5. Net Income (Loss) per Share This section details the calculation of basic and diluted net income or loss per share 6. Marketable Securities This section provides detailed information on the company's marketable securities 7. Inventory, net This section details the company's inventory balances and related accounting 8. Prepaid expenses and other current assets This section details the company's prepaid expenses and other current assets 9. Property and Equipment, net This section provides detailed information on the company's property and equipment 10. Accrued Expenses and Other Current Liabilities This section details the company's accrued expenses and other current liabilities 11. Leases This section provides detailed information on the company's lease obligations 12. 401(k) Plan This section describes the company's 401(k) retirement plan 13. Notes Payable, Preferred Stock and Stock Purchase Warrants This section details the company's debt instruments, preferred stock, and warrants Term Loans This section describes the company's term loan agreements Loan and Security Agreement This section details the terms of the company's loan and security agreement PPP Loan This section provides information on the Paycheck Protection Program loan Convertible Preferred Stock and Warrants This section details the company's convertible preferred stock and associated warrants Equity Line Agreement This section describes the company's equity line agreement Securities Purchase Agreement This section details the terms of the securities purchase agreement Convertible Notes This section provides detailed information on the company's convertible notes PHC Notes This section describes the PHC convertible notes 2025 Notes This section details the convertible notes due in 2025 2023 Notes This section describes the convertible notes due in 2023 14. Stockholders' Deficit This section details the components of the company's stockholders' deficit Common Stock This section provides information on the company's common stock Preferred Stock This section provides information on the company's preferred stock Voting Rights This section describes the voting rights associated with the company's shares Dividends This section outlines the company's dividend policy and history Conversion Rights This section details the conversion rights of certain securities Stock Purchase Warrants This section provides information on the company's stock purchase warrants 15. Stock-Based Compensation This section details the accounting for stock-based compensation plans and awards 2015 Plan This section describes the company's 2015 stock incentive plan Inducement Plan This section details the company's inducement equity plan Commercial Equity Plan This section describes the company's commercial equity plan 2016 Employee Stock Purchase Plan This section details the company's 2016 employee stock purchase plan 1997 Plan This section describes the company's 1997 stock incentive plan Stock Options This section provides information on the company's stock option awards Restricted Stock Units This section details the company's restricted stock unit awards 16. Income Taxes This section provides detailed information on the company's income tax position 17. Related Party Transactions This section details transactions between the company and its related parties 18. Fair Value Measurements This section provides information on the fair value of financial instruments 19. Litigation This section details any ongoing or pending legal disputes involving the company 20. Subsequent Events This section describes significant events occurring after the balance sheet date Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure The company reported no changes in or disagreements with accountants on accounting or financial disclosure matters - No changes in or disagreements with accountants on accounting and financial disclosure were reported699 Item 9A. Controls and Procedures Management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of December 31, 2023, concluding they were effective at a reasonable assurance level. No material changes in internal control over financial reporting were identified during the quarter, and management concluded that internal control over financial reporting was effective as of December 31, 2023 - As of December 31, 2023, the company's disclosure controls and procedures were evaluated and deemed effective at the reasonable assurance level by management, including the CEO and CFO699 - No material changes in internal control over financial reporting were identified during the quarter ended December 31, 2023700 - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023, based on the COSO framework701 Item 9B. Other Information During the fiscal quarter ended December 31, 2023, no officers or directors adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - No officers or directors adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the fiscal quarter ended December 31, 2023704 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to the company - The company is not subject to disclosures regarding foreign jurisdictions that prevent inspections705 PART III This part incorporates by reference information on corporate governance, executive compensation, security ownership, and auditor fees Item 10. Directors, Executive Officers and Corporate Governance Information regarding the company's directors, executive officers, and corporate governance, including Section 16(a) beneficial ownership reporting compliance, is incorporated by reference from the 2024 Proxy Statement - Information on directors, executive officers, corporate governance, and Section 16(a) beneficial ownership reporting compliance is incorporated by reference from the 2024 Proxy Statement708 Item 11. Executive Compensation Information concerning executive and non-employee director compensation is incorporated by reference from the 2024 Proxy Statement - Information on executive compensation and non-employee director compensation is incorporated by reference from the 2024 Proxy Statement708 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Details regarding security ownership of certain beneficial owners and management, along with securities authorized for issuance under equity compensation plans, are incorporated by reference from the 2024 Proxy Statement - Information on security ownership of certain beneficial owners and management, and securities authorized for issuance under equity compensation plans, is incorporated by reference from the 2024 Proxy Statement709 Item 13. Certain Relationships and Related Transactions, and Director Independence Information on certain relationships, related transactions, and director independence is incorporated by reference from the 2024 Proxy Statement - Information on certain relationships, related transactions, and director independence is incorporated by reference from the 2024 Proxy Statement709 Item 14. Principal Accountant Fees and Services Information regarding principal accountant fees and services is incorporated by reference from the 2024 Proxy Statement - Information on principal accountant fees and services is incorporated by reference from the 2024 Proxy Statement710 PART IV This part lists financial statement schedules and exhibits, and includes the required corporate signatures for the report Item 15. Exhibit and Financial Statement Schedules This section lists the financial statements and exhibits filed as part of the Annual Report on Form 10-K. It indicates that consolidated financial statements are presented in Part II, Item 8, and all financial schedules have been omitted as the information is either presented in the financial statements/notes or is not applicable. A comprehensive list of exhibits, including corporate documents, agreements, and certifications, is provided - Consolidated Financial Statements are listed in Part II, Item 8 of this Annual Report on Form 10-K712 - All financial schedules are omitted because the required information is presented in the consolidated financial statements or notes, or is not applicable713 - A comprehensive list of exhibits, including corporate documents, agreements, and certifications, is filed as part of this Annual Report or incorporated by reference714 Item 16. Form 10-K Summary This item is not applicable to the company - The company is not providing a Form 10-K Summary719 Signatures This section contains the required signatures for the Annual Report on Form 10-K, including those of the President and Chief Executive Officer, Chief Financial Officer, and members of the Board of Directors, affirming their authorization and compliance with the Securities Exchange Act of 1934 - The Annual Report on Form 10-K is duly signed by the President and Chief Executive Officer, Chief Financial Officer, and members of the Board of Directors, as required by Section 13 or 15(d) of the Securities Exchange Act of 1934722724725726